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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	BIDMC-2003P-000182 NCT00073957

Trial Description

Purpose:

Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.

Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Received at least one previous chemotherapy regimen
• Measurable disease
• No CNS lymphoma
• No previous autologous bone marrow transplantation, peripheral stem cell transplantation, or radioimmunotherapy
• More than 2 weeks since filgrastim or sargramostim
• More than 4 weeks since surgery
• More than 4 weeks since treatment for lymphoma
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive an infusion of indium In 111 ibritumomab tiuxetan on day 1. They will then undergo imaging procedures. Patients will receive a 3- to 4-hour infusion of rituximab once a week for 6 weeks and an infusion of yttrium Y 90 ibritumomab tiuxetan in week 2. They will also receive either intrathecal methotrexate or intrathecal cytarabine once a week in weeks 3-6 or intrathecal liposomal cytarabine once a week in weeks 3 and 5.

Beginning in month 6, some patients will receive a 3- to 4-hour infusion of rituximab once a week for 4 weeks. Treatment may be repeated every 6 months for up to 2 years.

Patients will be evaluated every 3 months for 2 years and then every 6 months for 2 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Beth Israel Deaconess Medical Center

Robin Joyce, MD, Protocol chair		Ph: 617-667-9920 Email: rjoyce@bidmc.harvard.edu

U.S.A.
Massachusetts
	Boston
	Beth Israel Deaconess Medical Center
		Clinical Trials Office - Beth Israel Deaconess Medical Center	Ph:  617-667-9925
Vermont
	Burlington
	Fletcher Allen Health Care - Medical Center Campus
		Clinical Trials Office - Fletcher Allen Heakth Care	Ph:  802-656-8990

Registry Information
Official Title		Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Trial Start Date		2003-12-02
Trial Completion Date		2010-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00073957
Date Submitted to PDQ		2003-10-17
Information Last Verified		2009-07-05

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